Characteristic | Northern Denmark | United Kingdom | ||||
---|---|---|---|---|---|---|
3 months (n=95) | 6 months (n=109) | 12 months (n=77) | 3 months (n=820) | 6 months (n=1256) | 12 months (n=800) | |
Baseline mean (SD) | 9.5 (3.6) | 9.3 (3.4) | 9.1 (3.5) | 8.6 (3.2) | 8.7 (3.2) | 8.7 (3.4) |
Follow-up mean (SD) | 9.2 (3.7) | 9.0 (3.4) | 9.1 (3.5) | 8.8 (3.2) | 8.8 (3.1) | 8.7 (3.1) |
Change from baseline, mean (95% CI) | −0.38 (−9.0 to 8.2) | −0.27 (−8.2 to 7.6) | 0.01 (−7.3 to 7.3) | 0.27 (0.04 to 0.49) | 0.08 (−0.12 to 0.27) | 0.03 (−0.22 to 0.28) |
Proportion with a clinically meaningful* increase, per cent (95% CI) | 40 (31 to 50) | 35 (26 to 44) | 32 (23 to 43) | 39 (36 to 43) | 40 (38 to 43) | 40 (37 to 44) |
Proportion with a clinically meaningful* decrease, per cent (95% CI) | 39 (30 to 49) | 35 (26 to 44) | 40 (30 to 51) | 30 (27 to 33) | 33 (31 to 36) | 34 (31 to 38) |
N with FPG >10 mmol/L after baseline/N with baseline FPG ≤10 mmol/L | 14/65 | 18/79 | 8/54 | 98/610 | 182/911 | 99/583 |
New postdiscontinuation onset of treatment failure, FPG >10 mmol/L, per cent (95% CI)† | 22 (13 to 33) | 23 (15 to 33) | 15 (7.3 to 26) | 16 (13 to 19) | 20 (18 to 23) | 17 (14 to 20) |
*Clinically meaningful change defined using the European Medicines Agency's definition as change of more than 10 mmol/L.
†Assessed in patients without evidence of treatment failure before discontinuing rosiglitazone.